Kornimate/medical-research-clean huggingface dataset:
evaluation of the use of the relax® glasses on the anxiety of patients undergoing emergency hand surgery under locoregional anesthesia

Conditions: Surgery

Summary: more than 90% of hand surgery is performed under local anesthesia and can be a source of anxiety, especially in an emergency context. the management of this intraoperative anxiety is essential for the comfort. the use of a virtual reality headset has shown its effectiveness in reducing anxiety in dental surgery or hand surgery under local anesthesia with the walant technique. on the other hand, virtual reality and the use of 3d can cause discomfort and side effects such as nausea and dizziness. it is known that audiovisual distraction also effectively reduces pain and anxiety in patients with fewer side effects. the investigators have therefore chosen to use the relax® glasses. there are no publications examining the effectiveness of positive distraction as a non-pharmacological agent to improve the patient experience during emergency management in the operating room in the context of hand surgery under locoregional anesthesia. the investigatos would like to study its action on the anxiety, pain and global satisfaction.


Eligibility criteria:
inclusion criteria: * patients treated for hand surgery under emergency locoregional anesthesia (wounds, fractures and infections of the hand and wrist). * over 15 years and 3 months of age on the day of inclusion. * patient with written consent or additional parental consent in the case of minor patients. * socially insured patient. * patient willing to comply with all study procedures and duration. exclusion criteria: * medical history contraindicating relax glasses: claustrophobia. * known and current alcohol and/or illicit drug abuse that may interfere with patient safety and/or compliance. * any condition that would make the patient unfit for the study: current presence of cognitive impairment (mms \<15), severe psychiatric disorders (bipolar disorder, psychotic disorders according to the dsm-v classification). * pregnant or breastfeeding woman. * patient under court protection. * patient participating in another study. * patient's refusal to use the headset.

Keywords: audiovisual sedation anxiety hand surgery locoregional anesthesia
compare the efficacy of rosuvastatin to atorvastatin in high risk patients with hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: this trial is to compare the efficacy, safety and tolerability of rosuvastatin with atorvastatin by assessing the change of ldl-c in patients with hypercholesterolemia and history of coronary heart disease (chd) or risk equivalent, or a 10 year chd risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.


Eligibility criteria:
inclusion criteria: * treated for or diagnosed hypercholesterolemia or have had a high risk with hypercholesterolemia * ldl-c between 3.36mmol/l and 6.5 mmol/l if not treated with statin or between 2.6mmol/l and 4.14 mmol/l * fasting triglyceride less than 4.52mmol/l exclusion criteria: * history of statin induced myopathy * unstable or uncontrolled cardiovascular diseases * familial dysbetalipoproteinemia

Keywords: hmg-coa ldl-c chd
tailoring treatment in colorectal cancer

Conditions: Colorectal Neoplasms

Summary: in this study, the investigators will establish a reliable method and logistic pipeline for personalized drug testing ex vivo using fresh tumor samples from colorectal cancer (crc) patients. with this, the investigators aim to develop a novel predictive biomarker of immunotherapy response, by testing combinations of chemotherapies and chimeric antigen receptor (car) t cells. critically, this affects a large subgroup of patients currently not considered to benefit from such treatment. to support the hypothesis, the project will make use of cutting-edge, cell-based functional diagnostics. individual patients' cancer cells will be screened against a panel of chemotherapies and targeted therapies including car t cells, to assess the optimal combination of therapies to induce immunotherapy efficacy in otherwise unresponsive crc.

primary hypothesis: drug screening of patient-derived organoids is a feasible method to identify effective and ineffective therapies for personalized colorectal cancer treatment. secondary hypothesis: pre-treatment with cytotoxic agents can induce cellular immunotherapy efficacy against solid tumors in a colorectal cancer patient-derived organoid model. primary objective: to provide methodology and competencies for a clinical trial on drug screening on patient-derived organoids as an approach in personalized cancer treatment. secondary objective: to explore induction of cellular immunotherapy efficacy in colorectal cancer patient-derived organoids by chemotherapy or targeted agents.

Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal cancer scheduled for curative surgery and standard clinical follow-up. exclusion criteria: - unable/unwilling to sign the informed consent form.

Keywords: leucovorin oxaliplatin fluorouracil immunotherapy colorectal cancer car t-cells patient-derived organoids
lower extremity neuromuscular assessment in children with cerebral palsy

Conditions: Force Measurement; Electromyography; Children; Cerebral Palsy; Lower Limb

Summary: the purpose of this study is to evaluate the reliability (intra-rater and inter-rater) of the k-pull dynamometer and the k-myo non-invasive electromyography sensor (assessing neuromuscular activity) in the evaluation of the lower limbs in children with cerebral palsy. specific objectives include: * examining differences in neuromuscular activity among children with cp classified at functional levels i to iii on the gmfcs scale. * deriving conclusions from the correlation between electromyographic activity, muscle tone, and generated muscle strength. * assessing the applicability of neuromuscular activity assessment devices in clinical settings.


Eligibility criteria:
inclusion criteria: * children with spastic type cerebral palsy (cp), * aged between 5 and 16 years, * classified at gmfcs levels i to iii, * voluntary motor control, * ambulatory, with or without the use of mobility aids, * can understand and execute verbal commands. exclusion criteria: * have previously undergone interventions that affect neuromuscular performance (such as surgery or botulinum toxin injections) * have sustained an injury, * demonstrate a low level of compliance.

Keywords: dynamometry electromyography cerebral palsy child lower limb
pre-prostatectomy mri-guided stereotactic body radiotherapy for high-risk prostate cancer trial (prepare sbrt)

Conditions: Prostate Cancer

Summary: men with prostate cancer with gleason score of 8 or greater or clinical/radiographic evidence of t3 disease will be considered for this trial.

patients with a diagnosis of high risk prostate cancer with a gleason score of 8 or greater are eligible for this trial. the study will enroll 20 subjects in 3 years. this is a single arm study and the primary objectives is to assess if a patient can undergo a radical prostatectomy after sbrt without a post-operative grade 3 or higher toxicity (according to clavien-dindo classification) at 30 days. secondary objectives are to assess acute toxicity and quality of life scores. exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction mris.

Eligibility criteria:
inclusion criteria: * men aged greater than equal to18 with histologically confirmed primary prostate cancer. * kps greater than equal to 70 * patient with a negative staging bone scan. * patient can undergo an mri. * patient with negative staging ct or mri of pelvis. suspicious evidence of nodal involvement on staging ct or mri of pelvis is defined as greater than 1 cm on short axis. documented negative biopsy of suspicious node required. * patient is medically fit to undergo prostatectomy. * patient has either gleason score greater than equal to 8 on biopsy and/or clinical/radiographic evidence of t3 disease. exclusion criteria: * prior history of receiving pelvic radiotherapy. * patient is unwilling to undergo prostatectomy. * patient with active inflammatory bowel disease defined as currently receiving therapy for ibd.
risk factors for acute kidney injury in diabetic patients

Conditions: Diabete Mellitus

Summary: incidence of aki in diabetic patients seems to be influenced by multiple risk factors like severe infections, elderly, poor diabetic control, previous aki, chronic kidney disease and drugs like sglt2-i increase risk of aki in diabetic patients.

the incidence and prevalence of diabetes mellitus (dm) have increased over the last 20 years. the defining feature of diabetes mellitus (dm) is the presence of hyperglycaemia . mostly due to the progressively increasing prevalence of obesity and the metabolic syndrome, current prevalence of dm worldwide is estimated to be about 390 million people . the cardiovascular complications increase morbidity and mortality in diabetic patients. about 40% of end-stage renal disease on regular dialysis are diabetic . acute kidney injury (aki) is a fundamental problem in hospitalized patients; its incidence has been reaching 20% in middle-europe . about 50% of patients presented with aki are found to be diabetic ; which may indicate a direct relationship between the two conditions. in 2012, a clinical practice guideline published by kidney disease: improving global outcomes (kdigo) provided a unifying definition and staging system for aki . on the other hand, incidence of aki in diabetic patients seems to be influenced by multiple risk factors like severe infections, elderly, poor diabetic control, previous aki, chronic kidney disease and drugs like sglt2-i increase risk of aki in diabetic patients. we aim in this study to identify the most common risk factors for aki in diabetic patients and how those risk factors affect morbidity and mortality in patients with dm who developed aki.

Eligibility criteria:
inclusion criteria: - inclusion criteria for the cases : 200 diabetic patients of 18 year and older (either type 1or 2) presented by aki based on kidigo definition \& staging. kdigo definition of aki: increase in serum creatinine by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 h, or increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or urine volume \<0.5 ml/kg/h for 6 h. kdigo staging of aki: (1) stage 1: serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dl (≥26.5 µmol/l) increase / urine output \<0.5 ml/kg/h for 6-12 h (2) stage 2; serum creatinine 2.0-2.9 × baseline / urine output \<0.5 ml/kg/h for ≥12 h (3) stage 3: serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dl (≥353.6 µmol/l), initiation of renal replacement therapy, or, in patients \<18 years, decrease in egfr to \<35 ml/min per 1.73 m2 / urine output \<0.3 ml/kg/h for ≥24 h or anuria for ≥12 h . inclusion criteria for matched controls 200 diabetic patients of 18 year and older with no aki (either type 1or 2) exclusion criteria: exclusion criteria for cases and controls: 1. non-diabetic patients with aki 2. diabetic patients with: * hbs ag, hcv, hiv * active lupus * active malignancy * acute or chronic liver disease * acute poisoning
the effect of cognitive behavioral therapy and virtual reality use in inured athletes

Conditions: Re-injury Anxiety; Kinesiophobia; Poor Rehabilitation Adherence; Poor Rehabilitation Self Efficacy; Return to Sport

Summary: in this study, which aimed to develop a cognitive behavioral therapy (cbt) protocol enriched with virtual reality (vr) to address the psychological responses that arise after acl surgery, and to examine the effectiveness of this protocol. the effectiveness of the protocol was assessed using pre-test, post-test, and two follow-up measurements with the re-injury anxiety inventory (riai), the sport injury rehabilitation adherence scale (siras), the tampa scale for kinesiophobia (tsk), the athletic injury self-efficacy questionnaire (aiseq), the return to sport after serious injury questionnaire (rssiq), and the anterior cruciate ligament return to sport scale (acl-rsi). anxiety levels during vr exposure sessions were measured through biofeedback and the subjective units of distress scale (suds).

in this study, which aimed to develop a cognitive behavioral therapy (cbt) protocol enriched with virtual reality (vr) to address the psychological responses that arise after acl surgery, and to examine the effectiveness of this protocol. the protocol was developed in 5 stages and a randomized controlled trial was conducted with 36 athletes to test its effectiveness. the study consisted of 1 experimental and 2 control groups. one of the control group was a plasebo control group.the effectiveness of the protocol was assessed using pre-test, post-test, and follow-up measurements with the re-injury anxiety inventory (riai), the sport injury rehabilitation adherence scale (siras), the tampa scale for kinesiophobia (tsk), the athletic injury self-efficacy questionnaire (aiseq), the return to sport after serious injury questionnaire (rssiq), and the anterior cruciate ligament return to sport scale (acl-rsi). anxiety levels during vr exposure sessions were measured through biofeedback and the subjective units of distress scale (suds).

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * have had an acl injury operation * be between the ages of 18 and 45 * to be a professional athlete in turkish leagues * being an athlete in football, volleyball, and basketball exclusion criteria: * having a discomfort that prevents participants from participating in vr sessions (panic attack, epilepsy, etc.) * having motion sickness susceptibility (the athlete's score from the " motion sickness susceptibility questionnaire" will be decisive.) * having decided to quit sports even if participants will continue rehabilitation after the operation

Keywords: re-injury anxiety adherence self-efficacy kinesiophobia psychological readiness to return to sport
frequency of pompe's disease and neuromuscular etiologies in patients with restrictive respiratory failure associated with signs of muscle weakness

Conditions: Pompe Disease

Summary: a breach of respiratory function may be one of the elements more or less early or predominant clinical picture of neuromuscular diseases. it is considered that the obstructive syndromes represent 64% and restrictive or mixed syndromes 36% of chronic respiratory insufficiency, approximately 7% due to a neuromuscular disease. the frequency and type of impairment are dependent on the underlying pathology. the neuromuscular restrictive respiratory failure (irr) remains partially unknown pulmonologists, especially because the signs of muscle weakness are sometimes difficult to detect. however, respiratory diseases are a major concern in neuromuscular diseases because they can have an impact both on sleep (not sleep, ...) on the daily activities (breathlessness on exertion, dyspnea) and thereby alter the quality of life of patients. moreover, they represent a significant morbidity and mortality factor. chest tightness may in some cases reveal the disease and thus constitute the chief complaint of a patient with a neuromuscular disease. in late-onset pompe disease, lung disease is the predominant clinical symptoms in about 30% of patients. an algorithm was developed to guide practitioners and help them in their diagnostic approach to the cause of the irr (diagnostic algorithm ats / ers 2005). however, this algorithm does not allow precise identification of the neuromuscular causes. at the patient level, this can have an impact by extending the time before placing a diagnosis. in pompe disease, the average time to diagnosis reached 7.9 years. however, there are for this disease a simple and rapid diagnostic test. therefore, a greater awareness of practitioners with regard to the particular pompe disease and neuromuscular diseases in general may be beneficial to patients. this study aims to: i) awareness pulmonologists to the possibility of neuromuscular an irr. ii) characterize the frequency of neuromuscular origin of irr in a broad population of patients with concomitant signs muscle weakness. iii) reduce the time to diagnosis by directing patients to neuromuscular reference center early.


Eligibility criteria:
inclusion criteria: * presence of a cv \<80% of predicted and / or \<lin * presence spirometry a report tiffeneau (fev / cv) equal to or higher than normal * signature of informed consent * men and women age ≥ 18 years * production of a medical examination * affiliated to social security exclusion criteria: * restrictive breath traumatic * restrictive respiratory failure associated with parenchymal disorder, whether localized or diffuse * known neuromuscular disease associated with a restrictive lung disease * patient under guardianship, curatorship, protected by law * inability to cooperate * morbid obesity with a bmi ≥40
exercise therapy in mental disorders-study

Conditions: Schizophrenia and Related Disorders; Bipolar Disorder

Summary: the study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. the overall aim is to determine which of the two is superior in a long-term perspective.

background: patients with severe mental disorders (smd), including schizophrenia spectrum and bipolar disorders, frequently experience suboptimal treatment effectiveness resulting in disabling residual symptoms and cognitive challenges, and have elevated mortality risk amounting to 15-20 years of shortened life expectancy compared to the general population. cardiovascular disease (cvd) is a major contributor in this regard. exercise in general improves cognitive functioning, negative symptoms, quality of life, and reduces the risk of cvd. high intensity training (hit) has been shown to be feasible for persons with smd, but attrition and noncompliance are substantial and likely to limit the effectiveness of hit. a less strenuous hit could increase adherence to the intervention, which might compensate for a slightly lower efficacy compared to standard hit. our study will compare standard 4x4-min hit to a 4-min single-bout hit session, as well as explore exercise effects on basic processes in the body. methods: patients with schizophrenia spectrum and bipolar disorders are eligible for participation, and those included will be randomized to 26 weeks of either 1) standard 4 x 4 min hit at treadmill, or 2) short 1 x 4 min hit at treadmill. to reduce dropout, the intervention will usually be delivered in group format, and conducted under the supervision of a physical therapist in collaboration with a postdoctor. the research group has a stable staff with research nurses, biostatisticians and researchers that will secure the dayto- day conductance of the project, including psychometric assessments, drawing of and biobanking of blood, as well as data collection and storing. measures: mental and cognitive symptoms, quality of life, motivation, peak oxygen uptake (v

Eligibility criteria:
inclusion criteria: * icd-10 schizophrenia-spectrum disorder (f2) * icd-10 bipolar disorder (f3) * capacity to provide informed consent. exclusion criteria: * contra-indication for exercise training and testing according to the american college of sports medicine specifications * life threatening or terminal medical conditions * not able to carry out intervention or test procedures * current pregnancy * mothers less than 6 months post-partum.

Keywords: exercise therapy effectiveness
rezafungin pharmacokinetics in patients on ecmo

Conditions: Sepsis

Summary: extracorporeal membrane oxygenation (ecmo) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. it is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. there is a need to understand how ecmo circuits affect the pharmacokinetics and disposition of drugs. this study is designed to assess the pharmacokinetics of the new broad-spectrum echinocandin, rezafungin, in critically ill patients receiving ecmo

this is a prospective, open-label, phase 1b, pharmacokinetic study of rezafungin in 8 critically ill patients receiving ecmo support at hartford hospital. informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. this is not a treatment study; all participants will receive other antibiotics as necessary to treat any current infection.

Eligibility criteria:
inclusion criteria: * age 18 years or older * receiving venovenous or venoarterial ecmo support. exclusion criteria: * females who are pregnant or breast-feeding * history of any moderate or severe hypersensitivity or allergic reaction to any echinocandin antifungal * receiving rezafungin to treat documented or suspected infection within 14 days of screening, or expected to receive rezafungin during the study intervention phase * receiving or likely to require intermittent hemodialysis * a hemoglobin less than 7.2 gm/dl at baseline * acute liver injury, defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 5 times the upper limit of normal, or ast or alt \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal * patients expected to have ecmo discontinued within the next 24 hours * any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator) * any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data

Keywords: pharmacokinetics echinocandins
intraperitoneal mcy-m11 (mesothelin-targeting car) for treatment of advanced ovarian cancer and peritoneal mesothelioma

Conditions: Peritoneal Mesothelioma; Fallopian Tube Adenocarcinoma; Adenocarcinoma of the Ovary; Primary Peritoneal Carcinoma

Summary: this is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of mcy-m11 when administered as an intraperitoneal (ip) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy. the study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.


Eligibility criteria:
inclusion criteria: * be able to undergo peripheral blood leukapheresis; have successful placement of an intraperitoneal catheter * be diagnosed with one of the following: metastatic or unresectable high grade serous adenocarcinoma involving the ovary, primary peritoneum, or fallopian tube with peritoneal involvement, not including mixed histologies, or unresectable epithelioid or biphasic peritoneal mesothelioma * be at least 4 weeks from previous anti-cancer therapy * have a life expectancy of greater than 3 months. exclusion criteria: * females who are pregnant, trying to become pregnant, or breastfeeding * diagnosis of hiv or chronic active hepatitis b or c * symptomatic or uncontrolled brain metastases requiring current treatment * impaired cardiac function or clinically significant cardiac disease * lack of recovery of prior mild adverse events due to earlier therapies * active infection * another previous or current malignancy within the last 3 years, with exceptions * concomitant chronic use of steroids or nsaids * concomitant use of complementary or alternative medication or therapy * autoimmune disease or inflammatory disease within previous 5 years

Keywords: platinum resistant high grade serous adenocarcinoma recurrence after chemotherapy intraperitoneal